Phase 1/2 clinical study of niraparib in combination with pembrolizumab in patients with advanced or metastatic triple-negative breast cancer and in patients with recurrent ovarian cancer

• TNBC who have been treated with at least 1 prior regimen for advanced/metastatic disease or who relapsed/progressed while on or within 1 month from completion of adjuvant chemotherapy
• Up to 3 lines of prior therapy allowed in Phase 1 portion, Up to 2 lines allowed in Phase 2 portion
• May not have progressed while on platinum treatment or within 1 month from completion of platinum-containing regimen in any line
• Measurable disease by RECIST 1.1
• ECOG PS 0-1
• No active CNS mets (stable for at least 4 weeks and resolution of symptoms are allowed)
• No additional malignancy within 5 years (except non-melanoma skin, in situ of  cervix)
• No chronic systemic steroid use
• No active autoimmune disease that has required treatment in last 2 years
• No history of interstitial lung disease
• No history of platelet transfusion for chemo-induced thrombocytopenia
• No prior anti-PD1 or PARP therapy

Primary- Safety; Secondary- Safety, ORR, DOR, DCR, PFS, OS, PK